The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea

Last updated: November 13, 2024
Sponsor: RAND
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Hyponatremia

Lactose Intolerance

Treatment

Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc

Clinical Study ID

NCT06444633
HCAAD201
  • Ages > 15
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. The primary research questions for the study are:

  • RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?

  • RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?

  • RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?

All wards in Bauchi state will be randomly assigned to one of two groups:

  • treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment

  • delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.

A total of 1,732 enumeration areas (EAs) will be sampled across all wards for the study period. Within each EA, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 15 years old

  • Has at least one child under 5 at baseline

  • Proficiency in English or Hausa

Exclusion

Exclusion Criteria:

  • Living in a temporary home (nomadic population)

  • Does not speak English or Hausa

  • Unable to give informed consent

Study Design

Total Participants: 103920
Treatment Group(s): 1
Primary Treatment: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
Phase:
Study Start date:
September 04, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Clinton Health Access Initiative

    Abuja,
    Nigeria

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.